- CEO
- Michael W. Dunne
- Full Time Employees
- 9
- Sector
- Healthcare
- Industry
- Biotechnology
- Address
- 3 Dublin Landings Dublin Ireland D01 C4E0
- IPO Date
- May 25, 2018
- Business
- Iterum Therapeutics plc is a clinical-stage pharmaceutical company focused on developing and commercializing anti-infective therapies to address multi-drug resistant pathogens, led by its lead asset sulopenem in oral and intravenous formulations. Headquartered in Dublin, Ireland, the company operates primarily to advance novel penem antibiotics with potential applications in urinary tract infections and other serious bacterial infections, targeting both hospital and community settings.
Main products and services
- Sulopenem portfolio: oral and IV formulations of sulopenem, a novel penem antibiotic designed to treat a broad range of Gram-positive and Gram-negative infections, including uncomplicated urinary tract infections (uUTI) and complicated UTIs (cUTI) and other serious infections under development; associated drug delivery systems, dosing regimens, and formulation development support for clinical trials and potential commercialization
- Antimicrobial susceptibility testing collaborations: diagnostic tools and companion offerings that support susceptibility testing to guide therapy, including development and potential commercialization of disc-based or assay formats to aid clinicians in selecting effective anti-infectives
- Collaboration and licensing services: strategic partnerships with pharmaceutical and biotech companies, pharmaceutical distributors, and health plans for market access, distribution, and reimbursement activities; ongoing capability building in regulatory filings and clinical trial support
- Regulatory and lifecycle services: regulatory strategy, data generation, and submission management for potential approvals in key jurisdictions; post-approval pharmacovigilance and labeling updates as applicable
- Research and development services: preclinical and clinical development support for antimicrobial compounds, including study design, biomarker development, resistance surveillance, and pharmacokinetic/pharmacodynamic analyses
Latest major company changes
- Strategic partnerships and market access expansions: signings of commercial contracts and rebate agreements with major pharmaceutical benefit managers (PBMs) and health plans to broaden formulary coverage for ORLYNVAH™ (sulopenem) in the United States, expanding potential patient access to over 24 million lives and positioning ORLYNVAH for formulary inclusion beginning in early 2026; these arrangements indicate a shift toward early payer engagement and commercial readiness in anticipation of broader adoption
- FDA interactions and regulatory updates: ongoing discussions with the U.S. FDA regarding step-down therapy claims for sulopenem and anticipated written responses with a targeted date in early 2026, reflecting active regulatory progression and potential pathway to expanded indications; FDA engagement complements market access activities
- Intellectual property and global expansion: patent protections secured in key markets such as China and Mexico for anti-infective formulations, supporting broader geographic expansion and competitive positioning; the company also highlights advancing antimicrobial susceptibility testing capabilities to strengthen clinical use cases
- Financial and operational updates: continued focus on sustaining operations into 2026 through cash reserves and fundraising activities, with management signaling exploration of additional financing options to extend runway while pursuing product development and potential commercialization activities
Additional context
- Industry and segments: biopharmaceuticals with emphasis on anti-infectives, infectious disease therapeutics, and antimicrobial resistance solutions; research and development, regulatory affairs, and market access management are core business segments
- Target markets and customers: hospital and outpatient clinicians treating UTIs and other bacterial infections; payers including PBMs and health plans; academic and government research partners
- Geographic operations: headquarters in Dublin, Ireland, with activities and regulatory proceedings in the United States and other international markets as development progresses
- Founding year and corporate structure: Iterum Therapeutics plc established to develop sulopenem-based therapies; operates as a public-company listing with a focus on commercial-stage execution once regulatory approvals and payer access are established
- Subsidiaries and parent relationships: operates as a standalone publicly listed company with potential collaboration and licensing arrangements that connect it to external partners and licensees for development, manufacturing, and distribution activities
Note: Information is based on publicly available sources and company materials as of early 2026, including regulatory updates, market access announcements, and patent activity related to ORLYNVAH™ and sulopenem.